FDAFDA · Food and drugs·Recall number Z-2059-2018
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Published June 13, 2018 · Recall initiated: May 4, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Randox Laboratories
- Distributor
- US Distribution including Puerto Rico and the state of : West Virginia.
- Lot
- GTIN 05055273206104. All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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